NCT01192503

Safety and Efficacy of Rasagiline in Restless Legs Syndrome

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.

Detailed description

The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile for the treatment of RLS, as measured by the International RLS Study Group Rating Scale (IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12. The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures of global clinical change, sleep quality, excessive sleepiness, quality of life, or depressive symptoms.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	rasagiline	1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
DRUG	placebo (sugar pill)	1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2010-09-01
• Last updated: 2013-02-11

Locations

8 sites across 1 country: United States